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Comparing Measurements Made in an Incremental Shuttle Walk Test and a Cardiopulmonary Exercise Test in Patients With IPF

Study Purpose

Idiopathic pulmonary fibrosis (IPF) is a chronic and potentially fatal lung disease. As IPF progresses, patients become increasingly breathless with reduced exercise capacity and quality of life. A cardiopulmonary exercise test (CPET) is a gold standard way of assessing patients with IPF. An incremental shuttle walk test is simpler, cheaper, more widely available and anecdotally preferable to CPET. The investigators will compare the measurements made in an ISWT and a CPET in patients with IPF . We aim to determine whether sufficient information can be gathered in an ISWT to negate the need to undertake CPET.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Observational
Eligible Ages	16 Years - 90 Years
Gender	All

More Inclusion & Exclusion Criteria

Inclusion Criteria:

- Diagnosis of idiopathic pulmonary fibrosis confirmed by a multi-disciplinary team.

- Aged 16 or over.

- Able to give informed consent to take part.

- Able to undertake both a cycle ergometry test and an incremental shuttle walk test without needing walking aids.

Exclusion Criteria:

- An inability to give informed consent.

- Taking part in a research project with a potentially research-modifying intervention.

- Currently pregnant.

- Currently breastfeeding.

- Unable to perform an incremental shuttle walk test.

- Unable to perform an incremental cycle ergometry test.

- Unable to walk without an aid such as a stick or frame.

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT03360032
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	University Hospitals Coventry and Warwickshire NHS Trust
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	David Parr
Principal Investigator Affiliation	University Hospitals Coventry and Warwickshire NHS Trust
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Other
Overall Status	Recruiting
Countries	United Kingdom
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Idiopathic Pulmonary Fibrosis

Additional Details

Idiopathic pulmonary fibrosis (IPF) is a chronic and potentially fatal lung disease. As IPF progresses, patients become increasingly breathless with reduced exercise capacity and quality of life. Average life expectancy is three years from diagnosis but IPF progresses at different rates in different people. In 2012 the British Lung Foundation estimated that 32,500 in the UK had IPF. An accurate prognosis can help determine the most appropriate individual treatment option and allow patients and their families to make suitable plans. Currently, measurements from resting lung function tests are used to predict prognosis. However, measurement made during CPET are more sensitive survival predictors and CPET is the gold standard test to assess prognosis in IPF. A CPET test is relatively time-consuming and requires specialist equipment that is not universally available. CPET is not routinely used in clinical practice for the assessment of IPF. The incremental shuttle walk test (ISWT) is quicker, cheaper and more widely available than CPET. This study builds on previous research done by the Respiratory team which showed a linear relationship between the distance walked in an ISWT and peak oxygen consumption during a CPET, a useful prognostic predictor, in patients with interstitial lung disease. 40-50 patients with IPF will be recruited and will undertake both ISWT and CPET at University Hospital, Coventry. The investigators will compare the results in the current cohort to those of the previous study. Additionally, the research team will compare oxygen pressure in capillary blood at the end of an ISWT and a CPET. The investigators will also compare patient experience of the two tests using questionnaires. This study paves the way for a simple, standardised test to more accurately predict prognosis in IPF.

Arms & Interventions

Arms

: All participants

All patients will be asked to undertake an incremental shuttle walk test and a cardiopulmonary exercise test and the results will be compared.

Interventions

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